510(k) · Cleared
Recalled · Class II · 2014Infiniti (R) Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · HQC Unit, Phacofragmentation
Cleared on Jun 15, 2012 as substantially equivalent to K112425 (Alcon Manufacturing, Ltd., 2011) and 5 other predicates after an 81-day review. Its family tree reaches back 6 generations to 1985. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 15, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K844373 (1985). 29 ancestors in all, the oldest K842458 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 5 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 4 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 3 generations backK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- 2 generations backK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- 1 generation backK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- This deviceK120912 Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK193376 Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020
Most influential descendants
Showing 3 of 3 · See all- K141065Constellation Vision SystemAlcon Research, Ltd. · 2014 · cites it directly2descendants
- K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · 2 generations on0descendants
- K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −5 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −4 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −3 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| −2 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| −1 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| 0 (this device) | K120912 | Infiniti (R) Vision System | Alcon Manufacturing, Ltd. | 2012 | — |
| +1 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
| +2 | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | 2 |
| +2 | K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceSummary page 1…per 21 CFR 886.4670 Predicate Devices: The legally marketed devices(s) to which we are claiming equivalence to are: 510(k) numberDevice K1 12425 INFINITI® Vision System (Evergreen 11) K093210 AquaL-ase Capsule Wash Tip K091 777… | 2011 |
| * | K093210 | Aqualase Capsule Wash TipSummary page 1…ly marketed devices(s) to which we are claiming equivalence to are: 510(k) numberDevice K1 12425 INFINITI® Vision System (Evergreen 11) K093210 AquaL-ase Capsule Wash Tip K091 777 Alcon UltraChopper Tip K082845 INFINIT… | 2010 |
| * | K091777 | Alcon UltrachopperSummary page 1…nce to are: 510(k) numberDevice K1 12425 INFINITI® Vision System (Evergreen 11) K093210 AquaL-ase Capsule Wash Tip K091 777 Alcon UltraChopper Tip K082845 INFINITI" Vision System with OZil® IP K063155… | 2009 |
| * | K082845 | Infiniti Vision System with Ozil IPSummary page 1…25 INFINITI® Vision System (Evergreen 11) K093210 AquaL-ase Capsule Wash Tip K091 777 Alcon UltraChopper Tip K082845 INFINITI" Vision System with OZil® IP K063155 Monarch Ill Delivery System (includes C & 0 cart… | 2009 |
| * | K063155 | Monarch Iii Iol Delivery SystemSummary page 1…10 AquaL-ase Capsule Wash Tip K091 777 Alcon UltraChopper Tip K082845 INFINITI" Vision System with OZil® IP K063155 Monarch Ill Delivery System (includes C & 0 cartridges) K021 566 INFINITI® Vision System Devi… | 2007 |
| * | K021566 | InfinitiSummary page 1…hopper Tip K082845 INFINITI" Vision System with OZil® IP K063155 Monarch Ill Delivery System (includes C & 0 cartridges) K021 566 INFINITI® Vision System Device Description The INFINITI® Vision System is unchanged from the INFINITI® Visi… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141065 | Constellation Vision System | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2014 | Class II | Z-0506-2015 | Process control | Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 10 of the 29 ancestors have a recall of any class.
- Of its descendants, K141065 (Alcon Research, Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K112425.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® Autoer® ]IL Injector Handpiece is intended to deliver qualified AcrySoftm intraocular lenses into the eye following cataract removal. The following…
Read the full statement (149 words)
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® Autoer® ]IL Injector Handpiece is intended to deliver qualified AcrySoftm intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaL-ase achieves the functionality for removal of residual cortical material and lens epithelial cells
- The INTREPID®D Autoert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® Autoert®' lOL Injector Handpiece is indicated for use with ACRYSOF lenses SNGOWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySofo lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120912 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120912: Infiniti (R) Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120912
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026